Clinical Trial: Glucocorticoids and Bone in Graves' Ophthalmopathy

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Observational

Official Title: The Effect of 4.5 Gram Methylprednisolone Administered Once Weekly for 12 Weeks on Bone Metabolism in Graves´ Ophthalmopathy

Brief Summary: Continuous use of systemic glucocorticoids decreases bone mineral density and increases fracture risk. Graves' orbitopathy is treated with weekly infusion of high-dose intravenous glucocorticoid. The investigators aim at investigating whether this treatment regimen also affects bone metabolism.

Detailed Summary:

Systemic glucocorticoid increases bone resorption and decreases bone formation and thereby decreases bone mineral density and increases fracture risk. This effect is evident with a daily dose of 5 mg for three months or an accumulated dose of 450mg. There is, however, less evidence that intermittent use of glucocorticoids is harmful to bone.

Graves orbitopathy is treated with a weekly infusion of the glucocorticoid methylprednisolone and the accumulated dose over a 12-week course sums up to 4,500mg.

The investigators therefore want to investigate if that treatment regimen affects bone turnover, bone mineral density, or bone structure in 30 patients with Graves' orbitopathy.


Sponsor: Torben Harsløf

Current Primary Outcome: Lumbar spine bone mineral density [ Time Frame: 12 weeks ]

Change in lumbar spine bone mineral density from baseline to week 12


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Femoral neck bone mineral density [ Time Frame: 12 weeks ]
    Change in femoral neck bone mineral density from baseline to week 12
  • Total hip bone mineral density [ Time Frame: 12 weeks ]
    Change in total hip bone mineral density from baseline to week 12
  • Bone turnover [ Time Frame: 12 weeks ]
    Change in bone turnover measured by the biochemical markers CTx and P1NP
  • Bone structure [ Time Frame: 12 weeks ]
    Change in bone structure measured by high-resolution peripheral quantitative computed tomography


Original Secondary Outcome: Same as current

Information By: Aarhus University Hospital

Dates:
Date Received: April 18, 2017
Date Started: May 2017
Date Completion: November 2019
Last Updated: April 20, 2017
Last Verified: April 2017